RESPECT patient needs

RESPECT: Relating Expectations and Needs to the Participation
and Empowerment of Children in Clinical Trials

Project overview

Studies have shown that over 50% of the medicinal products used in
children may not have been tested or authorised for use in this age
group. This leaves health care professionals with no alternative but to
use medicines "off-label", judging the suitability and the correct dose
of these medicines themselves in the absence of paediatric labeling
information. This poses significant risks of inefficacy and/or adverse
reactions for children.

The EU regulation (EC No. 1901/2006 on Medicinal Products
for Paediatric Use) came into effect in January 2007 to ensure that
medicinal products that are researched, developed and authorised in
Europe will also meet the therapeutic needs of children. This will mean
an increased demand for children to participate in clinical trials of
new medicines.

The European research project RESPECT, led by the Institute of
Clinical Sciences at the Sahlgrenska Academy at Gothenburg University,
Sweden, set out to identify the needs and motivations of children and
their families who have participated or might participate in clinical
trials in Europe.

We explored the issues raised by children's participation in medical research by speaking with paediatric patients and their parents, patient support organisations, paediatricians, ethical committees and representatives of the pharmaceutical industry to gather their experience, insights and suggestions. This enabled us to make recommendations for how to empower children such that medical researchers respect their interests and can motivate their participation in future clinical trials.

Please see the Publications below for our presentations and articles.

RESPECT: Main recommendations to stakeholders

A full description and discussion of these recommendations can be found in chapter 9 of the RESPECT book.

The RESPECT consortium consisted of experts from the fields of clinical research, patient representation, and European paediatric research ethics and regulation. The following experts were partners in the RESPECT project:

The EPF is a European umbrella NGO representing 44 chronic disease-specific patient organisations. The EPF works at the European level and with national coalitions of patients' organisations. EPF was the leading coordinator of the Value+ project promoting patients involvement in EU supported health-realted projects.

Consorzio per le Valutazioni Biologiche e Farmacologiche is a clinical research organisation conducting and monitoring CTs, particularly with Thalassaemia patients, and coordinator of the TEDDY European Network of Excellence.

Azienda Ospedaliera di Padova - Dept of Pediatrics, University of Padua has expertise in the area of paediatric CTs with a focus on HIV. They are leading the EU project GRIP and led the steering committee of the PENTA paediatric CTs network.

University Medical Centre Hamburg-Eppendorf has expertise in the areas of patient-reported outcome measures and the development of quality-of-life instruments for child self report (eg. (DISABKIDS). The Medical Psychology Dept. trains medical staff who will in the future conduct CTs with children.